Whatever you call it, low-cost biologics deferred for another day.(Biologics)

BOSTON -- One of the most divisive issues between the generics and innovator industries the last decade remains unresolved despite the passage of FDAAA--what to do about "follow-on" biologics--sometimes called generic biologics or biosimilars.

At the RAPS meeting here, attendees learned that efforts to provide lower-cost biotech drugs and vaccines in U.S. are coming from three different points of view:

* Rep. Henry Waxman (D-CA) and Sens. Charles Schumer and Hillary Rodham Clinton (D-NY) provided a startingpoint and were very pro-generic.

* Rep. Jay Inslee (D-WA) called for more adequate incentives for innovation.

* Sens. Edward Kennedy (D-MA), Orrin Hatch (R-UT0, Mike Enzi (R-WY) and Clinton worked on a compromise (S1695). Kennedy chairs the Senate Health, Education, Labor and Pensions (HELP) Committee and Enzi is ranking minority member.

To BIO's Sandra Dennis, S-1695 is "the one to watch. Biotech's not in love with the bill but it's a step in the right direction. The generic drug industry doesn't like it either."

Four key follow-on biologics issues are still in play: safety, interchangeability, exclusivity, and intellectual property rights.

The first issue is to establish safety without duplicative studies, though "when safety terms are defined, the definition tends to be circular," admitted Dennis. All bills consider, in various ways, degrees of similarity, the same routs of administration, dosage form, strength, and mechanism of action; and data from studies. The Waxman bill specifically states "any necessary clinical studies," the emphasis "discouraging the need for clinical studies," according to Dennis.

The interchangeability issues address the fact that biologics are different from chemical drugs, and science doesn't yet support an accurate comparison. "No patient should be exposed to risks higher than ones already in the former iteration," Dennis said.

She added, "Europe is ahead of us here--there's already a pathway ... and they prohibit interchangeability." The Kennedy bill, panelists noted, would allow substitution at the pharmacy level without physician involvement, though the bills run the gamut from substitution being permitted to prohibited.

Exclusivity is the key to preserving incentives for development, and all of the proposed bills recognize its importance. Proposals range from Waxman who would give zero years to Kennedy at 12 years. This is what Dennis calls an evergreen issue and the one to watch. She herself feels that the magic number should be 14, placing the biologic on common ground with chemical drugs, though the "patent protection for biologics," she admitted, "is less predictable."

There is no "Orange Book" for biologics, so the intellectual property rights issues are more difficult than they are for drugs; there's a real need for a similar information exchange in order to determine potential infringement. The Hatch/Waxman bill would resolve litigation before the biologic is marketed through patent listings and certification.

There are varying predictions on action this year. The Senate HELP committee has marked up the Kennedy bill, but there has been no action toward passage. More bills may yet be introduced. Story by Jeannette Cezanne

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